Cyclosporine API Manufacturer & Supplier in India

Cyclosporine is a potent calcineurin inhibitor immunosuppressant used to prevent organ rejection after transplantation (kidney, liver, heart) and to treat severe autoimmune conditions including rheumatoid arthritis, psoriasis, and atopic dermatitis. Mediocon Inc supplies pharmaceutical-grade Cyclosporine meeting IP/BP/EP/USP standards with an assay of 99.0% Min.

Key Features

• Calcineurin inhibitor – selective T-cell immunosuppressant
• IP/BP/EP/USP compliant, Assay 99.0% Min.
• Used in organ transplantation and autoimmune diseases
• Suitable for oral capsule, oral solution, and IV formulations

Applications

• Organ transplant rejection prevention
• Severe rheumatoid arthritis treatment
• Refractory psoriasis therapy
• Atopic dermatitis & uveitis formulations

Why Choose Mediocon

• ISO 9001:2015 & GMP certified manufacturing
• Consistent batch-to-batch quality with full CoA
• Export-ready documentation: COO, MSDS, DMF
• Flexible MOQ for both R&D and commercial scale
• Dedicated QA support for regulatory filings

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Cyclosporine (CAS 59865-13-3) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Cyclosporine is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — before release with a Certificate of Analysis.

Export Markets

• USA — FDA-registered facility; DMF support available for ANDA/NDA filings
• Europe — EMA-compliant documentation; CEP/EDMF support on request
• Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
• Southeast Asia — established logistics network; temperature-controlled shipments
• India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

• ISO 9001:2015 certified quality management system
• GMP-certified manufacturing facility, Aurangabad, Maharashtra
• Full batch traceability from raw material to finished API
• Stability data available (ICH Q1A guidelines) for regulatory submissions
• Dedicated QA team for customer audits and regulatory queries